Electronic Submission Expertise
Regulatory eSubmissions, LLC
Selected Merck & Co., Inc. Accomplishments
Selected Datafarm Inc. Accomplishments

Selected Datafarm Inc. Accomplishments
  • Managed a global staff located in the US, UK and India.
  • Produced eCTD/eSubmission deliverables for 70+ companies ranging from emerging Pharmaceutical/Biotechnology/CRO companies to the largest Tier 1 Pharmaceutical/CRO companies.  The deliverables include eCTDs/eSubmissions for all submission types and all regions (Types: eCTD {IND, BBIND, NDA, BLA, MAA, etc.}, NeeS, CTA, PSUR, VAR, DMF, Baselines, etc.; Regions: US, EU, Canada, Japan, etc.)
  • Business development lead for regulatory submission services new client prospects.  Resulted in Datafarm’s services group being chosen by several pharmaceutical companies and currently under consideration by others.  Represented were Tier 1 Pharmaceutical and CRO organizations.
  • Participated as a Session Chair at DIA 2009 Annual Meeting, speaker at the DIA 2009 eCTD Conference and the 2009 & 2010 DIA EDM Conference co-chair.  These activities were concentrated around electronic submission outsourcing, assembly, distribution and management.
  • Participate in HL7 Regulated Clinical Research Information Management (RCRIM) and Implementation of Regulatory Information Submission Standards (IRISS) Forum activities.
  • Other notable achievements: Standardized services pricing structure, standardized submission assembly infrastructure, provided specifications and oversaw the development of several linking tools, enhanced the organization’s industry visibility and implemented submission management processes.  These achievements resulted in significant improvements in project administration and eSubmission production throughput, consistency and quality. 

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